Home Applications 202992 Application 202992
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AUBAGIO TERIFLUNOMIDE TABLET;ORAL 7MG Yes No 002 AUBAGIO TERIFLUNOMIDE TABLET;ORAL 14MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202992-001 AUBAGIO TERIFLUNOMIDE 7MG TABLET / ORAL AB RLD 2012-09-12 N202992-002 AUBAGIO TERIFLUNOMIDE 14MG TABLET / ORAL AB RLD, RS 2012-09-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202992-001 6794410 2026-09-12 U-1285 2013-08-20 N202992-001 6794410*PED 2027-03-12 Pediatric extension N202992-001 8802735 2030-09-14 Drug product 2014-09-11 N202992-001 8802735*PED 2031-03-14 Pediatric extension N202992-001 9186346 2034-02-04 U-1786 2015-12-15 N202992-001 9186346*PED 2034-08-04 Pediatric extension N202992-002 6794410 2026-09-12 U-1285 2013-08-20 N202992-002 6794410*PED 2027-03-12 Pediatric extension N202992-002 8802735 2030-09-14 Drug product 2014-09-11 N202992-002 8802735*PED 2031-03-14 Pediatric extension N202992-002 9186346 2034-02-04 U-1786 2015-12-15 N202992-002 9186346*PED 2034-08-04 Pediatric extension
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Patent history page 1 of 12 · 444 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202992-001 6794410 2026-09-12 U-1285 2013-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-001 6794410*PED 2027-03-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-001 8802735 2030-09-14 Drug product 2014-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-001 8802735*PED 2031-03-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-001 9186346 2034-02-04 U-1786 2015-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-001 9186346*PED 2034-08-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-002 6794410 2026-09-12 U-1285 2013-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-002 6794410*PED 2027-03-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-002 8802735 2030-09-14 Drug product 2014-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-002 8802735*PED 2031-03-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-002 9186346 2034-02-04 U-1786 2015-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-002 9186346*PED 2034-08-04 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-001 6794410 2026-09-12 U-1285 2013-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-001 6794410*PED 2027-03-12 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-001 8802735 2030-09-14 Drug product 2014-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-001 8802735*PED 2031-03-14 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-001 9186346 2034-02-04 U-1786 2015-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-001 9186346*PED 2034-08-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-002 6794410 2026-09-12 U-1285 2013-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-002 6794410*PED 2027-03-12 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-002 8802735 2030-09-14 Drug product 2014-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-002 8802735*PED 2031-03-14 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-002 9186346 2034-02-04 U-1786 2015-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-002 9186346*PED 2034-08-04 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202992-001 6794410 2026-09-12 U-1285 2013-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-001 6794410*PED 2027-03-12 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-001 8802735 2030-09-14 Drug product 2014-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-001 8802735*PED 2031-03-14 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-001 9186346 2034-02-04 U-1786 2015-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-001 9186346*PED 2034-08-04 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-002 6794410 2026-09-12 U-1285 2013-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-002 6794410*PED 2027-03-12 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-002 8802735 2030-09-14 Drug product 2014-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-002 8802735*PED 2031-03-14 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-002 9186346 2034-02-04 U-1786 2015-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-002 9186346*PED 2034-08-04 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202992-001 6794410 2026-09-12 U-1285 2013-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202992-001 6794410*PED 2027-03-12 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202992-001 8802735 2030-09-14 Drug product 2014-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202992-001 8802735*PED 2031-03-14 Pediatric extension fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 108 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 28 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 58468-0210 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0210 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0210 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0210 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0210 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0210 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0210 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0210 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0210 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0210 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0210 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0210 Aubagio teriflunomide Genzyme Corp. NDA Current 58468-0210 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0210 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0211 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0211 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0211 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0211 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0211 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0211 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0211 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0211 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0211 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0211 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0211 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0211 Aubagio teriflunomide Genzyme Corp. NDA Current 58468-0211 Aubagio teriflunomide Genzyme Corporation NDA Current 58468-0211 Aubagio teriflunomide Genzyme Corporation NDA Current